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Cochlear implants for children andadults with severe to profounddeafness

Issued: January 2009

NICE technology appraisal guidance 166guidance.nice.org.uk/ta166

NICE has accredited the process used by the Centre for Health Technology Evaluation at NICE toproduce technology appraisals guidance. Accreditation is valid for 5 years from September 2009 andapplies to guidance produced since June 2008 using the processes described in NICE's 'The guide tothe methods of technology appraisal' (2008). More information on accreditation can be viewed atwww.nice.org.uk/accreditation

© NICE 2009

Contents1 Guidance ................................................................................................................................. 3

2 Clinical need and practice ....................................................................................................... 5

3 The technology........................................................................................................................ 8

4 Evidence and interpretation..................................................................................................... 11

4.1 Clinical effectiveness....................................................................................................................... 11

4.2 Cost effectiveness ........................................................................................................................... 14

4.3 Consideration of the evidence......................................................................................................... 19

5 Implementation ....................................................................................................................... 28

6 Recommendations for further research................................................................................... 29

7 Related NICE guidance........................................................................................................... 30

8 Review of guidance ................................................................................................................. 31

Appendix A: Appraisal Committee members and NICE project team ........................................ 32

A Appraisal Committee members.......................................................................................................... 32

B NICE project team.............................................................................................................................. 35

Appendix B: Sources of evidence considered by the Committee............................................... 36

Changes after publication........................................................................................................... 39

About this guidance.................................................................................................................... 40

Cochlear implants for children and adults with severe toprofound deafness

NICE technology appraisalguidance 166

© NICE 2009. All rights reserved. Last modified January 2009 of 40

1 Guidance

This technology appraisal examined the currently available devices for cochlear implantation. Noevidence was available to the Committee to allow recommendations to be made for devicesmanufactured by Neurelec.

1.1 Unilateral cochlear implantation is recommended as an option for people withsevere to profound deafness who do not receive adequate benefit fromacoustic hearing aids, as defined in 1.5.

If different cochlear implant systems are considered to be equally appropriate,the least costly should be used. Assessment of cost should take into accountacquisition costs, long-term reliability and the support package offered.

1.2 Simultaneous bilateral cochlear implantation is recommended as an option forthe following groups of people with severe to profound deafness who do notreceive adequate benefit from acoustic hearing aids, as defined in 1.5:

children

adults who are blind or who have other disabilities that increase their reliance onauditory stimuli as a primary sensory mechanism for spatial awareness.

Acquisition of cochlear implant systems for bilateral implantation should be at thelowest cost and include currently available discounts on list prices equivalent to 40%or more for the second implant.

1.3 Sequential bilateral cochlear implantation is not recommended as an option forpeople with severe to profound deafness.

1.4 People who had a unilateral implant before publication of this guidance, andwho fall into one of the categories described in 1.2, should have the option ofan additional contralateral implant only if this is considered to provide sufficientbenefit by the responsible clinician after an informed discussion with theindividual person and their carers.




1.5 For the purposes of this guidance, severe to profound deafness is defined ashearing only sounds that are louder than 90 dB HL at frequencies of 2 and4 kHz without acoustic hearing aids. Adequate benefit from acoustic hearingaids is defined for this guidance as:

for adults, a score of 50% or greater on Bamford–Kowal–Bench (BKB) sentencetesting at a sound intensity of 70 dB SPL

for children, speech, language and listening skills appropriate to age, developmentalstage and cognitive ability.

1.6 Cochlear implantation should be considered for children and adults only afteran assessment by a multidisciplinary team. As part of the assessment childrenand adults should also have had a valid trial of an acoustic hearing aid for atleast 3 months (unless contraindicated or inappropriate).

1.7 When considering the assessment of adequacy of acoustic hearing aids, themultidisciplinary team should be mindful of the need to ensure equality ofaccess. Tests should take into account a person's disabilities (such as physicaland cognitive impairments), or linguistic or other communication difficulties,and may need to be adapted. If it is not possible to administer tests in alanguage in which a person is sufficiently fluent for the tests to be appropriate,other methods of assessment should be considered.




2 Clinical need and practice

2.1 Hearing loss may be caused by interference with the transmission of soundfrom the outer to the inner ear (conductive hearing loss) or damage within thecochlea, the auditory nerve or auditory centres in the brain (sensorineuralhearing loss). In adults the most common cause of sensorineural hearing lossis presbycusis. This is a progressive condition caused by the loss of function ofhair cells in the inner ear, leading to deafness. Hearing loss in adults may alsobe caused by excessive exposure to noise, or by ototoxic drugs, metabolicdisorders, infections or genetic factors. Severe to profound hearing loss inchildren may have a genetic aetiology, or have prenatal, perinatal or postnatalcauses. These include conditions such as meningitis and viral infection of theinner ear (for example, rubella or measles), as well as premature birth andcongenital infections. Deafness that occurs before the development oflanguage is described as prelingual, whereas deafness that occurs after thedevelopment of language is described as postlingual.

2.2 Approximately 370 children in England and 20 children in Wales are born withpermanent severe to profound deafness each year. Approximately 90% ofthese children have two parents who can hear. About 1 in every 1000 childrenis severely or profoundly deaf at 3 years old. This rises to 2 in every 1000children aged 9 to 16 years. There are approximately 613,000 people olderthan 16 years with severe to profound deafness in England and Wales. In theUK around 3% of people older than 50 and 8% of those older than 70 yearshave severe to profound hearing loss. Approximately 40% of children who aredeaf and 45% of people younger than 60 years who are deaf have additionaldifficulties, such as other physical disabilities.

2.3 Deafness is not typically associated with increased mortality, and need not beassociated with significant morbidity. Some people who are deaf identify with acultural model of deafness in which deafness is not considered an impairment.These people, who often use sign language as their preferred language andgrow up as members of the 'Deaf community', may not perceive deafness tohave a major impact on their quality of life. However, for a child who is borndeaf within a hearing family or for a person who becomes deaf and is used tofunctioning in a hearing environment, deafness can have a significant impact




on their quality of life. For children, deafness may have significantconsequences for linguistic, cognitive, emotional, educational and socialdevelopment. Loss of hearing affects an adult's ability to hear environmentalnoises and to understand speech; this can affect their ability to take part intheir daily activities and be part of their usual social and professional networks,which can lead to isolation and mental health problems.

2.4 Services for people who are deaf aim to improve their quality of life bymaximising their ability to communicate, using the means most appropriate forthe person and their environment, and to enable the person to move safelywithin their environment. There are approximately 50,000 people in the UKwho communicate using British Sign Language. These are generally peoplewho were born deaf or became deaf shortly after birth. Most people who aredeaf use oral and aural communication supplemented by lip reading, cuedspeech (visual cues to clarify the sounds of English), signs (finger spelling orsign-supported English) and the written word. Regardless of the chosen meansof communication, people may also use powerful hearing aids to help themidentify environmental noises and to hear spoken language. However, forsome people there are too few functioning hair cells for hearing aids to be ofuse.

2.5 National frameworks covering audiology include the NHS Newborn HearingScreening Programme and the NHS Modernising Hearing Aid Servicesprogramme for children and adults. The NHS Newborn Hearing ScreeningProgramme screens all newborn babies within 26 days of birth for possiblehearing difficulties. Babies who at screening are identified as having possiblehearing difficulties are referred to NHS audiology services. Those who are thenconfirmed deaf should receive a hearing aid within 2 months. This initialdiagnosis is followed by ongoing support, which includes regular audiologicalassessment and consideration of the appropriateness of a cochlear implant(usually within the first year). Hearing services for adults are coordinated byaudiology departments and normally include a review every 4 years, althoughthis varies across the UK.

2.6 Potential candidates for cochlear implants are referred to one of the cochlearimplant centres in England and Wales, where they receive a multidisciplinary




assessment to determine whether they are suitable for cochlear implantation.Both audiological hearing and functional hearing are assessed as part of themultidisciplinary assessment, as well as other factors such as fitness forsurgery, structure of the cochlea, the presence of a functioning auditory nerveand the likely ability of the person to derive benefit from the stimuli producedby the cochlear implant system.

2.7 Audiological testing identifies the additional intensity that a pure tone soundmust possess to be detected relative to the intensity that can be detected byyoung adults without hearing impairment. Guidelines from the British CochlearImplant Group suggest that people who cannot hear sounds quieter than anaverage of 90 dB HL when tested at frequencies of 2 and 4 kHz withoutacoustic hearings aids would be considered for cochlear implantation if they donot derive adequate benefit from acoustic hearing aids.

2.8 Functional hearing is tested with optimum acoustic hearing aids and focuseson a person's ability to perceive speech. For adults, functional hearing isusually assessed using Bamford–Kowal–Bench (BKB) sentences. Guidelinesfrom the British Cochlear Implant Group state that an adult who identifies 50%or more of keywords at a sound intensity of 70 dB SPL in quiet conditions isconsidered to be deriving an adequate benefit from their hearing aids.Functional hearing in children is assessed through the development andmaintenance of speech, language, communication and listening skills that areappropriate for the age, developmental stage and cognitive ability of the child.For this reason no single test is used.

2.9 During the year ending March 2007, 374 adults and 221 children had unilateralcochlear implantations in England and 8 adults and 22 children in Wales. Afurther 451 adults and 446 children were under assessment. In the UK, in theyear ending March 2007, 32 bilateral implantations were performed in childrenand 11 in adults. A survey of 15 of the 18 cochlear implant centres in Englandand Wales showed that 704 children and adults had received a unilateralcochlear implant during the financial year ending March 2008. In addition,there were 77 children and adults who had received bilateral cochlearimplants. Of these, 39 were simultaneous implants and 38 were sequentialimplants.




3 The technology

3.1 Cochlear implant systems consist of internal and external components. Amicrophone and sound processor are worn externally behind the ear. Thesound processor is connected to a transmitter coil, which is worn on the side ofthe head. Data from the transmitter coil are passed to a receiver–stimulatorpackage that is implanted into a surgically fashioned depression in the mastoidbone. The receiver–stimulator translates the data into electrical pulses that aredelivered to an array of electrodes. These are placed surgically within thecochlea. The electrodes stimulate spiral ganglion cells that innervate fibres ofthe auditory nerve. The activation of electrodes provides a sensation ofhearing, but does not restore hearing.

3.2 The NHS buys cochlear implant systems under a long-term procurementcontract between the four manufacturers and the NHS Supply Chain. Theprocurement contract in use during this appraisal applied until 31 October 2008and there was an option for an extension of a further 24 months. The costs ofthe implant systems noted below are based on information from the NHSSupply Chain on the national procurement contract. In addition to the mainprocurement contract, manufacturers offer local discounts based on volume ofsales; therefore costs may vary in different settings. Except for the discount forthe Neurelec system, discounts for second implant systems are not part of theNHS Supply Chain contract, but are offered nationally by some manufacturers.

3.3 The Clarion CII Bionic Ear System and the HiResolution Bionic Ear System(Advanced Bionics UK) are indicated for adults (18 years or older) withpostlingual onset of severe to profound, bilateral sensorineural hearing loss(only hearing sounds with an intensity equal to or greater than an average of70 dB HL) who derive limited benefit from appropriately fitted hearing aids. Forchildren aged 12 months to 17 years the implants are indicated for profoundbilateral sensorineural deafness (only hearing sounds with an intensity equal toor greater than an average of 90 dB HL) who derive limited benefit fromacoustic hearing aids. The current NHS Supply Chain list price of the implantsystem (which includes the implant and processor) is £16,550 and the pricepaid by the NHS Supply Chain for the implant system is £14,900. Informationsupplied by the manufacturer indicates that a 40% discount on the list price for




a second implant (list price for implant without processor and without discount:£10,500) is only offered when the second implant is used for simultaneousbilateral implantation. A 25% discount on the list price of £10,500 is offeredwhen the second implant is used for sequential bilateral implantation. Nodiscounts are offered for the purchase of a second processor. Costs may varyin different settings because of negotiated procurement discounts.

3.4 The Nucleus 24 and Nucleus Freedom cochlear implants (Cochlear Europe)are indicated for adults (18 years or older) who have bilateral postlingualsensorineural hearing loss and who achieve limited benefit from binauralhearing aids. For children (aged 12 months to 17 years) the implants areindicated for bilateral sensorineural hearing loss if little or no benefit is derivedfrom binaural hearing aids. The implants are also indicated for adults who haveprelingual or perilingual profound sensorineural deafness and who obtain nobenefit from a hearing aid. However, the package insert notes that thesepeople are likely to have limited benefit from a cochlear implant. The currentNHS Supply Chain list prices of the Nucleus 24 and Nucleus Freedomcochlear implant systems are £14,350 and £15,250–£15,550 respectively. Theprice paid by the NHS is based on the volume acquired by each cochlearimplant centre and the manufacturer offers a 10% discount for every 10implant systems purchased. Additional information supplied by themanufacturer indicates that discounts for a second implant system (implantand processor) for bilateral cochlear implantation are offered on a case-by-case basis. Costs may vary in different settings because of negotiatedprocurement discounts.

3.5 The Pulsar CI-100 (MED-EL UK) is indicated for people with severe toprofound deafness who derive limited benefit from conventional acousticamplification in the best-aided condition. It is recommended that individualshave a trial of acoustic hearing aids unless this is contraindicated. The currentlist price of the Pulsar CI-100 cochlear implant system is £17,375 and the pricepaid by the NHS is £15,600. Discounts are available from the manufacturer,but the details of the discounts were provided as commercial in confidence.

3.6 The Digisonic SP (Neurelec) is indicated for adults and children with bilateralprofound to total sensorineural hearing loss. The price paid by the NHS Supply




Chain for the Digisonic cochlear implant system is £12,250. A 50% discount onthe second implant system for bilateral implantation is currently in place withthe NHS Supply Chain (equating to £18,375 for two implant systems).

3.7 Information on discounts was also obtained from a survey of the 18 cochlearimplant centres in England and Wales. Responses were received from 15centres: 3 paediatric centres, 2 adult centres and 10 with paediatric and adultcaseloads. Four of the centres that responded did not carry out any bilateralimplants during this period. The results of the survey suggested variation in thediscounts received by the implant centres. For sequential bilateral implantation,the discounts ranged from 0 to 40% for the second implant. For simultaneousbilateral implantation the range was 0–50% for the second implant.




4 Evidence and interpretation

The Appraisal Committee (appendix A) considered evidence from a number of sources(appendix B).

4.1 Clinical effectiveness

4.1.1 The Assessment Group identified studies of cochlear implants that includedadults and/or children with severe to profound deafness. The AssessmentGroup included only studies of multichannel cochlear implants that usedwhole-speech processing coding strategies, because these most closelyrepresent the type of device available to the NHS. The Assessment Groupincluded randomised and non-randomised controlled trials, including studies inwhich participants acted as their own controls.

4.1.2 The systematic review by the Assessment Group comprised 33 studies, ofwhich 13 involved adults and 20 involved children. Meta-analysis of the datawas not possible because of heterogeneity between the studies. Only twoimplant systems in the NHS contract (both supplied by Cochlear Europe) wererepresented in studies included in the systematic review. Three manufacturers– Advanced Bionics UK, Cochlear Europe and MED-EL UK – submittedadditional studies reporting the clinical effectiveness of their implant systems.Neurelec did not submit evidence of clinical effectiveness to this appraisal.

Children: unilateral cochlear implantation

4.1.3 Eight studies compared a unilateral cochlear implant with non- technologicalsupport (that is, without acoustic hearing aids, but permitting lip reading or signlanguage), and six studies compared unilateral cochlear implants with acoustichearing aids. In ten of the studies children acted as their own controls and infour of the studies there was a separate non-randomised control group. Thestudies reported benefits from cochlear implants in auditory, speech perceptionand speech production outcomes. In the four studies that reported statisticalsignificance, the benefits were statistically significant. Two of these studiessuggested that children who have devices implanted earlier may have betteroutcomes.




http://publications.nice.org.uk/cochlear-implants-for-children-and-adults-with-severe-to-profound-deafness-ta166/appendix-a-appraisal-committee-members-and-nice-project-team

http://publications.nice.org.uk/cochlear-implants-for-children-and-adults-with-severe-to-profound-deafness-ta166/appendix-b-sources-of-evidence-considered-by-the-committee

Children: bilateral cochlear implantation

4.1.4 Three studies compared bilateral cochlear implants with a unilateral cochlearimplant, and three studies compared bilateral cochlear implants with aunilateral cochlear implant and a contralateral hearing aid. In four studies thechildren acted as their own controls, whereas the other two studies included anon-randomised control group. Benefits were reported for auditory and speechperception outcomes with bilateral cochlear implantation. In the five studiesthat reported levels of statistical significance, three reported statisticallysignificant improvements in the ability to identify the direction from which asound is coming with bilateral cochlear implants. In addition, two studiesreported statistically significant improvements in speech perception in noisyconditions with bilateral cochlear implants. However, differences for speechperception outcomes in quiet conditions were statistically significant for onlytwo out of seven outcome measures.

Children: quality of life and education outcomes

4.1.5 None of the studies in the Assessment Group's systematic review reportedeither quality of life or educational outcomes. Further searches identified fourstudies that measured quality of life and seven studies that measurededucational outcomes. Studies assessing quality of life suggest that a cochlearimplant can improve a child's quality of life and their quality of life as perceivedby their parents.

4.1.6 The studies of educational outcomes suggest that children who are profoundlydeaf and have a cochlear implant may be more likely to be educated within amainstream school than children with a similar level of deafness but without acochlear implant. The studies also suggest that children who are profoundlydeaf and have a cochlear implant may have a higher level of academicperformance than those who are profoundly deaf but have no cochlear implant.

Adults: unilateral cochlear implantation

4.1.7 Four studies compared a unilateral cochlear implant with non-technologicalsupport (for example, without acoustic hearing aids, but permitting lip readingor sign language), and four studies compared a unilateral cochlear implant with




an acoustic hearing aid. In seven studies participants acted as their owncontrols; the eighth study included a non-randomised control group. Thestudies measured speech perception outcomes. Four also measured quality oflife and one measured an auditory outcome. The studies suggested that therewere benefits from the use of cochlear implants in all the outcomes measured.When statistical significance levels were reported, these benefits werestatistically significant, except for the auditory outcome. One study suggestedthat the benefits of a unilateral cochlear implant may be greater for youngerpeople and people who have been deaf for a shorter time.

Adults: bilateral cochlear implantation

4.1.8 Five studies compared unilateral cochlear implants with bilateral cochlearimplants. The Assessment Group did not identify any studies of adults thatcompared bilateral cochlear implants with a unilateral cochlear implant and acontralateral hearing aid. Two studies were randomised controlled trials and inthe other three, participants acted as their own controls. There was someoverlap in the participants included in three of the studies. The studiesmeasured auditory, speech perception and quality of life outcomes. Auditoryoutcomes were statistically significantly better for bilateral cochlear implantsthan for a unilateral implant. However, the results for speech perception andquality of life were more mixed, with some outcomes suggesting a negativeimpact of bilateral implantation owing to worsening of tinnitus after the secondimplantation.

Adults: quality of life

4.1.9 Three studies that measured quality of life were included in the systematicreview. However, because of the importance of this outcome, further searcheswere completed to identify other studies that measured quality of life. Sixfurther studies were identified, all of which reported benefits in quality of lifeassociated with cochlear implants. Four studies reported levels of statisticalsignificance, and three of these reported statistically significant benefits forquality of life after cochlear implantation.




4.2 Cost effectiveness

4.2.1 Submissions were received from three manufacturers. Two (Cochlear Europe,Advanced Bionics UK) provided de novo economic evaluations. The third(MED-EL UK) provided a narrative summary of existing published economicanalyses. The Assessment Group identified a total of nine studies that reportedcost-effectiveness or cost–benefit ratios from the perspective of the NHS.These reported ICERs (incremental cost-effectiveness ratios) for unilateralcochlear implantation ranging from £2000 to £20,000 per QALY gained forchildren and £11,000 to £18,000 per QALY gained for adults. In addition, theAssessment Group carried out a de novo economic evaluation.

The economic submission from Cochlear Europe

4.2.2 The manufacturer submitted a Markov model that evaluated the costeffectiveness of unilateral and bilateral cochlear implantation compared with'standard of care' (in which a proportion of people receive acoustic hearingaids) from an NHS and personal social services (PSS) perspective. Thedecision problem was assessed in relation to the Nucleus and NucleusFreedom products using costs and failure rates specific to these systems.Health-related utility data were derived from clinical studies and mappedspeech recognition scores onto HUI3 (health utility index 3) utility values. TheAssessment Group expressed concern about the way the mapping wasundertaken.

4.2.3 The comparison of unilateral implantation with 'standard of care' gave an ICERof £10,500 per QALY gained for children with severe to profound sensorineuraldeafness and £7100 per QALY gained for adults with postlingual severe toprofound sensorineural deafness. The comparison of bilateral implantation andunilateral implantation gave an ICER of £39,000 and £32,900 per QALY gainedin adults and children, respectively.

The economic submission from Advanced Bionics UK

4.2.4 The manufacturer submitted a Markov model that evaluated the costeffectiveness of unilateral cochlear implantation compared with no cochlearimplants from an NHS and PSS perspective. Four specific subgroups were




identified: children with prelingual profound deafness; children with postlingualprofound deafness; adults with postlingual profound deafness; and adults withpostlingual severe deafness. Cost-effectiveness analyses were not presentedfor bilateral cochlear implantation.

4.2.5 Costs were derived from a published study of cochlear implantation in children,and applied to both children and adults. Health-related utility data were derivedfrom published studies using HUI3. The ICERs associated with unilateralimplantation at 3 and 6 years were £13,300 and £17,200 per QALY gained,respectively. The ICERs for unilateral implantation in 50-year-old adults withprofound and severe deafness were £20,000 and £37,000 per QALY gained,respectively.

The economic submission from MED-EL UK

4.2.6 The submission from the manufacturer does not include an economic modeland primarily summarises some of the existing published economic literature.The submission presents an ICER of approximately £18,000 per QALY gainedfor unilateral cochlear implantation in children. For adults, estimates of costeffectiveness for unilateral cochlear implantation are presented for the groupas a whole and for two subgroups: adults with profound deafness who deriveno functional benefit from acoustic hearing aids; and adults with profounddeafness who derive some functional benefit from hearing aids. Thecorresponding ICERs were £20,600, £19,200 and £25,400 per QALY gained,respectively.

The economic model from the Assessment Group

4.2.7 The Assessment Group developed a Markov model to consider two questions.The first was the cost effectiveness of unilateral cochlear implantationcompared with standard treatment (which may or may not include acoustichearing aids) in children and adults who were profoundly deaf. The secondwas the cost effectiveness of providing an adult or a child who is profoundlydeaf and currently receiving standard treatment (which may or may not includeacoustic hearing aids) with a simultaneous or sequential (defined as 3 yearsbetween the first and second implant) bilateral cochlear implant compared witha unilateral cochlear implant.




4.2.8 The effectiveness of cochlear implants in the model was based on a separatereview of studies that reported health-related utility values for severe orprofound deafness for unilateral or bilateral cochlear implantation. The mostrelevant studies that were identified derived quality of life data from the HUI3.For children, changes in quality of life were reported by their parents or theirteachers as proxies. In the base-case analyses, utilities were assumed toremain constant over the lifetime of the person.

4.2.9 The health-related utility for a child without a cochlear implant was obtainedfrom all children in the UK with profound deafness and no cochlear implant.The health-related utility value from this population was 0.421. The gains inhealth-related utility from having a cochlear implant were 0.066, 0.212 and0.232 in the first 2 years following implantation, 2 to 4 years and 4 yearsonwards, respectively. The health-related utility data for adults were obtainedfrom a prospective cohort study that measured health-related utility before andafter cochlear implantation in a group of adults with postlingual severe toprofound deafness. The utility value without a cochlear implant was 0.433. Thegain in utility associated with having a unilateral cochlear implant wasestimated to be 0.197.

4.2.10 The health-related utility data for bilateral implantation were obtained from datafrom 24 adults with postlingual deafness who had a unilateral cochlear implantand were then randomised to receive a second contralateral implantimmediately or 11 months later. At 9 months follow-up a comparison of thosewho had bilateral implants with those waiting for their second implantsuggested a difference in utility of 0.10. A subsequent analysis of the wholegroup (before and after implantation) suggested a utility gain of –0.015.Regression analyses of the trial data, controlling for changes in tinnitus afterimplantation, suggested that the additional utility gain associated with bilateralcochlear implantation was 0.03. The Assessment Group used the latter value(0.03) in their analyses. In the absence of health-related utility data for bilateralcochlear implantation in children, the data from adults were applied to children.

4.2.11 The Assessment Group was unable to identify adequate health-related utilitydata to model the cost effectiveness of implanting a second device in a personwith one established cochlear implant. The Assessment Group did not




examine the following subgroups in its economic analysis: children and adultswith severe deafness; adults with prelingual deafness; children with postlingualdeafness; and children and adults who are both deaf and blind or are deaf andhave other disabilities. This was because of the lack of health-related utilitydata to define either the health-related utility without a cochlear implant or thegain in health-related utility following cochlear implantation.

4.2.12 Costs included in the model are taken from two large UK costing studies thatidentified the cochlear implant centre costs associated with cochlearimplantation in adults and children. The cost data for adults were taken fromthe same study from which utility data were taken. The data for children werecollected from a survey of UK cochlear implant centres providing cochlearimplants for the financial year 1998–9. In the base-case analyses, the cost ofthe cochlear implant (£14,661) was the mean cost of the nine devices in theNHS Supply Chain purchasing contract. For bilateral implantation, the cost of asingle device was doubled (£29,222). Discounts on the second implant systemwere considered in sensitivity analyses.

Cost effectiveness for children

4.2.13 The ICER for unilateral implantation in children who are prelingually deaf andreceive an implant at the age of 1 year was £13,400 per QALY gained. Thecorresponding ICERs for simultaneous and sequential bilateral implantationcompared with unilateral implantation were £40,400 and £54,100 per QALYgained, respectively.

4.2.14 Analyses suggested that the estimates of cost effectiveness were sensitive tothe time horizon, maintenance costs and utility. Scenario analyses thatincluded educational costs or a later age at implantation had little impact on theestimates of cost effectiveness. Sensitivity analyses suggested that theestimates of cost effectiveness for simultaneous bilateral implantation weresensitive to changes in device costs and the utility gained. With a cost of£14,661 for a unilateral implant system, reductions of 25 and 50% in the costof the second implant system reduced the ICER for simultaneous bilateralimplantation to £36,139 and £31,900 per QALY gained, respectively. Without acost discount for the second implant system, an increase of the utility gain from




0.03 to 0.04 reduced the ICER from £40,400 to £31,300 per incremental QALYgained.

4.2.15 The Assessment Group conducted additional two-way sensitivity analyses toinvestigate the impact of combining the discounts reported by the cochlearimplant centres (see section 3.7) with alternative assumptions about utility gainassociated with bilateral implantation for simultaneous bilateral cochlearimplantation in children. In the analyses, the cost of a unilateral implant systemwas assumed to be £15,534, which was the mean of the published list pricesof the devices used in the cochlear implant centres. Assuming a discount of30% on the second implant system and a utility of 0.03 produced an ICER of£36,040 per QALY gained. When the 30% discount was maintained and autility of 0.04 instead of 0.03 was assumed, the ICER was reduced to £27,886per QALY gained. Increasing the utility gain to 0.05 further reduced the ICERto £22,740 per QALY gained.

Cost effectiveness for adults

4.2.16 The ICER for unilateral implantation in adults who are postlingually deaf was£14,200 per QALY gained. The corresponding ICERs for simultaneous andsequential bilateral implantation compared with unilateral implantation were£49,600 and £60,300 per QALY gained, respectively.

4.2.17 Analyses suggested that the estimates of cost effectiveness were sensitive tothe time horizon, age of the cohort, device costs and utility gain. Scenarioanalysis using an age-dependent utility gain had little impact on the estimate ofcost effectiveness. Sensitivity analyses for simultaneous bilateral implantationshowed that the estimates were sensitive to changes in device costs and theutility gained. Reductions of 25 and 50% in the cost of the second implantsystem reduced the estimate of cost effectiveness to £43,028 and £36,497 perQALY gained, respectively. Without a cost discount for the second implantsystem, but with a utility gain of 0.04 as opposed to 0.03 the estimate of costeffectiveness was reduced from £49,600 to £37,725 per incremental QALYgained.

4.2.18 Following completion of the assessment report, consultees provided newevidence on the additional utility gain associated with bilateral compared with




unilateral implantation for children and adults. One estimate came from across-sectional study of 15 children with unilateral cochlear implants and 26children with bilateral cochlear implants. In this study, parents rated theirchildren's health-related quality of life using the HUI3. The utility of childrenwith a unilateral cochlear implant was reported as 0.72, whereas the utility ofchildren with bilateral cochlear implants was reported as 0.73, reflecting achange in utility of 0.01. A second estimate came from a study of 23 people(children and adults) with bilateral cochlear implants. In this study participantswere asked to retrospectively rate their health-related quality of life using theHUI3 before and after receiving a unilateral implant (that is, unilateral versusno implants). Participants were then asked to rate their health-related quality oflife using the HUI3 with bilateral implants. This study reported a utility of 0.69associated with unilateral cochlear implantation compared with 0.81 forbilateral cochlear implantation, which was reported in the paper as a change inutility of 0.11. A further study asked 180 people including parents, cliniciansand students to rate the hypothetical health-related quality of life of childrendescribed in vignettes. This study reported utility values of 0.77 for a child witha unilateral cochlear implant, 0.82 for a child using a unilateral cochlear implantand a contralateral hearing aid, and 0.88 for a child with bilateral cochlearimplants.

4.3 Consideration of the evidence

4.3.1 The Appraisal Committee reviewed the data available on the clinical and costeffectiveness of cochlear implants for children and adults with severe toprofound deafness, having considered evidence on the nature of the conditionand the value placed on the benefits of cochlear implants by people who aredeaf, those who represent them, and clinical specialists. It was also mindful ofthe need to take account of the effective use of NHS resources.

4.3.2 The Committee considered the distinction between audiological and functionaldeafness. The Committee heard from clinical specialists that audiologicalhearing was not necessarily related to functional hearing. Therefore, in clinicalpractice a person's hearing is assessed not just by audiological tests, but alsoby a functional test of hearing, specifically their ability to perceive speech inquiet conditions with acoustic hearing aids. The Committee concluded that




decisions about the appropriateness of cochlear implants should take intoconsideration a person's functional hearing and the benefit they gain fromacoustic hearing aids.

4.3.3 The Committee considered how functional deafness could be defined in clinicalpractice. It heard from clinical specialists that guidelines for adults from theBritish Cochlear Implant Group recommend Bamford–Kowal–Bench (BKB)sentence testing. Using this approach, an adequate benefit from hearing aidsis defined as a score of 50% or greater at a sound intensity of 70 dB SPL. TheCommittee heard that tests for children should assess whether speech,language and listening skills are appropriate to the age, development stageand cognitive ability of the child. The Committee heard that the mostappropriate test would differ according to the age and developmental stage ofthe child. The Committee considered that the BKB sentences may not beappropriate for assessing hearing in adults for whom English is a secondlanguage, and for adults with other linguistic or cognitive difficulties. TheCommittee considered that those making the hearing assessments should takethese factors into account. In these situations, modification of the testingprocedure or alternative tests may be required.

4.3.4 The Committee recognised that identifying people for whom cochlearimplantation was appropriate took account of not only the results ofaudiological and functional hearing tests but also other factors such as fitnessfor surgery, structure of the cochlea, the presence of functioning auditorynerves and the likelihood of benefiting from the stimuli produced by the device.The Committee heard from clinical specialists that these factors wereassessed as part of a multidisciplinary assessment, which would also include atrial of acoustic hearing aids that usually lasts for 3 months, if this was notcontraindicated or inappropriate. The Committee concluded that it wasessential to determine the appropriateness of cochlear implantation through amultidisciplinary assessment, with input from a range of professionals involvedin the care of children and adults with cochlear implants. This was in additionto audiological and functional hearing tests and a valid trial of acoustic hearingaids that usually lasted 3 months.




4.3.5 The Committee considered the perspective of people who may not considerdeafness a disability that needs to be treated. The Committee heard fromclinical specialists that most children who are deaf have families who arehearing and who have no access to 'Deaf culture'. In addition, it is unlikely thatadults who become deaf will become proficient users of sign language andintegrate into the 'Deaf community'. The Committee concluded that for manypeople deafness would have a significant adverse impact on their quality oflife, and that it was appropriate to consider cochlear implants as a means ofreducing this impact.

4.3.6 The Committee noted that the evidence for clinical and cost effectiveness wasderived from data based on cochlear implant systems from threemanufacturers of cochlear implants (Advanced Bionics UK, Cochlear Europe,MED-EL UK), and that no data for clinical effectiveness were identified forcochlear implant systems from the fourth manufacturer (Neurelec). TheCommittee was aware that cochlear implant systems from Neurelec areincluded in the current NHS procurement contract, but heard from clinicalspecialists that Neurelec implants are rarely used in the NHS. The Committeeconcluded that it was only able to issue recommendations about the devicesfor which there was evidence available.

4.3.7 The Committee examined the evidence for the clinical effectiveness of the useof unilateral cochlear implants for adults and children with severe to profounddeafness. The Committee considered that, despite methodological limitations,the studies showed benefits for providing unilateral cochlear implantscompared with hearing aids or non-technological support for people who wereappropriately assessed. The Committee concluded that unilateral cochlearimplants had been shown to be clinically effective.

4.3.8 The Committee examined the evidence for the cost effectiveness of unilateralcochlear implantation. The Committee noted that both the Assessment Groupand the manufacturers obtained similar estimates of cost effectiveness. TheCommittee considered that the analyses of cost effectiveness for unilateralimplantation were a reasonable reflection of the costs and benefits. TheCommittee concluded that unilateral cochlear implantation for adults and




children with severe to profound deafness who did not derive adequate benefitfrom acoustic hearing aids would be a cost-effective use of NHS resources.

4.3.9 The Committee considered the evidence for the clinical effectiveness ofbilateral cochlear implants. The Committee considered that the additionalbenefits of bilateral cochlear implantation were less certain than the benefits ofunilateral cochlear implantation. This was because of the limitations of theevidence base owing to the small number of studies and the small numbers ofparticipants. However, the Committee considered that the studies had shownadditional benefits to having a second cochlear implant in relation to speechperception in noisy situations and directional perception of sound. TheCommittee heard from patient experts that they considered that there wereother benefits from bilateral cochlear implantation. These benefits includedeasier, less exhausting communication (for example, determining the directionof the sound in group conversations without unnecessary head movement).The Committee concluded that there were additional benefits of bilateralcochlear implants that had not been adequately evaluated in the publishedstudies, although these may vary among individuals.

4.3.10 The Committee heard from clinical specialists that it was important that theauditory nerve was provided with stimulation early in a child's developmentbecause it became less sensitive to stimulation as the child became older.Hence, failure to stimulate the auditory nerve early impaired the developmentof central pathways necessary for the appreciation and understanding ofsound. The Committee was persuaded on the basis of consultee commentsthat the potential benefits of bilateral auditory stimulation would apply to bothprelingual and postlingual children with severe to profound deafness becauseneurosensory development continues after the development of language. TheCommittee concluded that making a distinction between children based on thetime of language development would not be appropriate.

4.3.11 The Committee then considered the cost effectiveness of bilateral cochlearimplantation. The Committee first examined the cost of cochlear implantsystems and in particular the availability of nationally agreed discounts for thesecond cochlear implant system. The Committee noted that the current NHSSupply Chain contract only included one discount on a bilateral system from a




single manufacturer (Neurelec). The Committee then considered theinformation about discounts provided by the other three manufacturers. TheCommittee noted that two of the three manufacturers reported their discountsas being standardised and nationally available. The Committee recognised thatthese discounts were sometimes given on the implant alone and other timeson the whole implant system (that is implant plus processor), and that thiswould affect the total cost of the system. The Committee examined theinformation on discounts from the survey of cochlear implant centres(described in section 3.7). The Committee noted that there was some variationin the size of the discount received by the cochlear implant centres that wasnot reflected in the information from the manufacturers. The Committee notedthis did not appear to relate directly to volume of implants purchased. TheCommittee considered that the data showed that discounts of 40% or more onthe second implant were being attained by a large proportion of implantcentres, and therefore could be considered as being available nationally.Therefore the Committee concluded that it was appropriate for this size ofdiscount to be taken into account when considering the estimates ofincremental cost effectiveness of bilateral implantation.

4.3.12 The Committee then considered the cost effectiveness of bilateral cochlearimplantation in adults. The Committee noted that the base case economicanalyses provided by the Assessment Group obtained an ICER forsimultaneous bilateral cochlear implantation of approximately £50,000 perQALY gained. The Committee noted that the utility data used in this analysiswere associated with uncertainty because the data were derived from a smallnumber of adults over a short follow-up period. However, the Committee notedthat these were the only data available for people who had been studiedprospectively before and after they had received a second cochlear implant.Therefore the Committee considered that this was the most appropriate sourceof data for estimating health utility gain following a second implant. TheCommittee noted concerns from consultees about the impact of tinnitus on theutility results from this study. It accepted the analysis of the study data that hadcontrolled for the impact of tinnitus and gave a health utility gain following asecond implant of 0.03. Therefore the Committee considered that 0.03 wascurrently the most appropriate estimate of the additional utility gain for asecond implant for adults with severe to profound deafness. The Committee




noted the Assessment Group's assumption of no discount for the secondimplant in their base-case analysis. The Committee considered the situation ofa 25–50% discount on the second implant system as discussed in section4.2.17. Under these circumstances the ICER for bilateral implantation foradults was between £43,000 and £36,500. The Committee noted from theAssessment Group's analysis that with a utility gain of 0.03, discounts on thesecond implant system had to be greater than 75% for the ICER for bilateralimplantation in adults to fall between £20,000 and £30,000 per QALY gained.Therefore the Committee concluded that it was not possible to recommendroutine bilateral cochlear implantation in adults as a cost-effective use of NHSresources.

4.3.13 The Committee next examined the evidence for the cost effectiveness ofbilateral cochlear implantation for children with severe to profound deafness.The Committee noted that the Assessment Group had been unable to identifyany health-related quality of life data for bilateral cochlear implantation inchildren, and had used the data from adults for children (that is, an additionalgain in health-related utility of 0.03 for the second implant). The Committeenoted comments from consultees that for children with severe to profounddeafness, a utility gain of 0.03 could potentially be an underestimate. Thesecomments focused on the view that bilateral cochlear implantation could affordmore quality of life gains for children than for adults, through improvedlanguage learning and spatial awareness, which would increase opportunitiesfor interaction and communication, the ability to participate in play activities,and benefits from education. The Committee was persuaded that additionalutility gains for children above that for adults were plausible. However, the sizeof these additional gains was associated with considerable uncertainty, giventhat there were limited data for children, and for adults the additional gains inhealth-related quality of life were associated with methodological concerns.The Committee recognised that the economic analyses were sensitive to utilitygains, and that if the gain in utility for children was assumed to be more thanfor adults, the ICER for bilateral cochlear implantation would be considerablyreduced from the base case.

4.3.14 The Committee then considered the impact on the ICERs of combiningadditional gains in utility for simultaneous bilateral cochlear implantation of




children with discounts on the second implant. The Committee noted that the40% discount for the second cochlear implant for simultaneous bilateralimplantation, which was being received by many cochlear implant centres,equated to approximately 30% off the cochlear implant system (implant plusprocessor). The Committee noted that with a discount of 30% on the implantsystem and a utility gain of 0.04, the ICER for children would be £27,900 perQALY gained. If the same discount was applied and the utility gain wasassumed to be 0.05, then the ICER for children would be £22,700 per QALYgained. The Committee was mindful that the size of the additional utility gainfollowing simultaneous bilateral implantation for children was very uncertain,but was persuaded that with the discounts on second implants currentlyavailable, it could accept the uncertainty associated with the gains in utility.Therefore the Committee concluded that if cochlear implants for bilateralimplantation could be acquired at the lowest price, including a discountequivalent to 40% or more off the current list prices of the second implant, thensimultaneous bilateral cochlear implantation for appropriately assessedchildren with severe to profound deafness could be considered a cost-effectiveuse of NHS resources.

4.3.15 The Committee recognised that some people who were deaf could also be atrisk of ossification of the cochlea (for example, after meningitis). TheCommittee heard from clinical specialists that ossification caused damage tothe cochlea, which could make both initial implantation and successful re-implantation in the case of device failure difficult. The Committee noted that theincidence of ossification after meningitis is unclear. However, it understood thata minority of people at risk of cochlear ossification went on to have cochlearossification, and that the extent of the ossification varied. The Committee notedthe evidence that, in general, device failure rates after successful implantationwere low (less than 5% over 15 years), and considered that the probability ofcochlear ossification occurring in adults with severe to profound deafnesscombined with failure of the unilateral implant and an inability to re-implant thefirst ear was therefore likely to be very small. On balance the Committeeconsidered that this very low risk was not in itself a reason to recommendbilateral implantation in this group when for adults overall it had not consideredthis a cost-effective use of NHS resources.




4.3.16 The Committee recognised that there were additional considerations for peoplewho are deaf and also have other disabilities. The Committee heard fromclinical specialists that specifically for people who are both deaf and blind, thegains in quality of life following bilateral implantation are greater than forpeople who are not blind. This is because people who are deaf and blind relymore on auditory stimuli for spatial awareness. The Committee recognised thatin addition to people who are deaf and blind, there are people with other co-disabilities who also rely on auditory stimuli as a primary sensory mechanismfor spatial awareness. The Committee considered that these individuals wouldbe most appropriately identified by healthcare professionals as part of amultidisciplinary assessment. The Committee was persuaded by the evidencefrom clinical specialists that bilateral cochlear implantation did produce greaterquality of life gains for deaf people who are blind or have other co-disabilitiesthat increase reliance on hearing as a primary sensory mechanism for spatialawareness than it did for people who are deaf and who do not have otherdisabilities of this nature. The Committee agreed that the inclusion of discountsequivalent to 40% or more off the list prices of the second implant wasappropriate in the cost-effectiveness analyses, as these reflected currentnationally available discounts. The Committee was mindful of the uncertaintyover the magnitude of the additional quality of life gains associated withbilateral cochlear implantation in this group of people, but was persuaded thatusing the currently available discounts would result in an acceptable cost-effectiveness estimate. Therefore the Committee was persuaded that ifcochlear implants for bilateral implantation were acquired at the lowest price,including currently available discounts on list prices equivalent to 40% or moreoff the second implant, then it was appropriate to recommend bilateral cochlearimplantation in this group of people as a cost-effective use of NHS resources.

4.3.17 The Committee noted that sequential implantation was associated with highercost-effectiveness estimates than simultaneous bilateral implantation for bothchildren and adults, and therefore concluded that sequential bilateralimplantation is not an appropriate use of NHS resources. However, theCommittee recognised that some children who have previously receivedunilateral implants may now be considered to have met the criteria in thecurrent guidance for simultaneous bilateral implantation. Similarly, this is thecase for adults who are deaf and have other disabilities that increase their




reliance on auditory stimuli as a primary sensory mechanism for spatialawareness. The Committee considered that it is important to promote equity oftreatment between groups of people who are in the same circumstancesexcept that one group had previously had a unilateral cochlear implant and theother becomes eligible now. However, the Committee was mindful that theduration of deafness and length of time since unilateral implantation couldreduce the benefits of any additional contralateral cochlear implant. TheCommittee was persuaded that in situations where the responsible clinicianconsiders that an additional contralateral cochlear implant would providesufficient benefit, people in the above two groups who have already received aunilateral cochlear implant prior to publication of this guidance should have theoption of an additional contralateral implant. However, the Committeeconsidered that an additional implant should be offered only after a fullyinformed discussion between the individual person, their carers and cliniciansinvolved in their care.

4.3.18 The Committee noted that in the economic analyses cochlear implants hadbeen modelled as a class. The Committee was aware from clinical specialiststhat there may be differences between the devices, in particular the processingstrategies used. The Committee did not consider that it had beendemonstrated that the different cochlear implant systems were associated withdifferent cost-effectiveness profiles. Therefore it was not appropriate topreferentially recommend a specific device. However, the Committee didconsider that if there was more than one cochlear implant system that wasconsidered clinically appropriate, the least costly implant system, taking intoaccount discounts as available, should be used. The Committee recognisedthat the cost of a system would depend on the support package offered, thelong-term reliability of the device and whether it was to be used unilaterally orbilaterally.




5 Implementation

5.1 The Healthcare Commission assesses the performance of NHS organisationsin meeting core and developmental standards set by the Department of Healthin 'Standards for better health' issued in July 2004. The Secretary of State hasdirected that the NHS provides funding and resources for medicines andtreatments that have been recommended by NICE technology appraisalsnormally within 3 months from the date that NICE publishes the guidance.Core standard C5 states that healthcare organisations should ensure theyconform to NICE technology appraisals.

5.2 'Healthcare standards for Wales' was issued by the Welsh AssemblyGovernment in May 2005 and provides a framework both for self-assessmentby healthcare organisations and for external review and investigation byHealthcare Inspectorate Wales. Standard 12a requires healthcareorganisations to ensure that patients and service users are provided witheffective treatment and care that conforms to NICE technology appraisalguidance. The Assembly Minister for Health and Social Services issued aDirection in October 2003 that requires local health boards and NHS trusts tomake funding available to enable the implementation of NICE technologyappraisal guidance, normally within 3 months.

5.3 When NICE recommends a treatment 'as an option', the NHS must make sureit is available within the period set out in the paragraph above. This meansthat, if a patient has severe to profound deafness and the doctor responsiblefor their care thinks that cochlear implants are the right treatment, they shouldbe available for use, in line with NICE's recommendations.

5.4 NICE has developed tools to help organisations implement this guidance(listed below).

Costing report and costing template to estimate the savings and costs associatedwith implementation.

Audit support for monitoring local practice.




http://guidance.nice.org.uk/TA166

6 Recommendations for further research

6.1 The Committee recommended that a randomised controlled trial should becarried out to examine the benefit of bilateral cochlear implantation comparedwith unilateral cochlear implantation in adults with severe to profounddeafness.

6.2 The Committee recommended that data on the health-related quality of life ofchildren with bilateral cochlear implants should be collected and measured inaccordance with the NICE 'Guide to the methods of technology appraisal'.




7 Related NICE guidance

There is no related guidance for this technology.




8 Review of guidance

8.1 The review date for a technology appraisal refers to the month and year inwhich the Guidance Executive will consider whether the technology should bereviewed. This decision will be taken in the light of information gathered byNICE, and in consultation with consultees and commentators.

8.2 The guidance on this technology was considered for review in June 2011.Details are available on the NICE website.

Andrew DillonChief ExecutiveJanuary 2009




http://guidance.nice.org.uk/TA166/ReviewDecision

Appendix A: Appraisal Committee members and NICEproject team

A Appraisal Committee members

The Appraisal Committee is a standing advisory committee of NICE. Its members are appointedfor a 3-year term. A list of the Committee members who took part in the discussions for thisappraisal appears below. The Appraisal Committee meets three times a month except inDecember, when there are no meetings. The Committee membership is split into three branches,each with a chair and vice-chair. Each branch considers its own list of technologies and ongoingtopics are not moved between the branches.

Committee members are asked to declare any interests in the technology to be appraised. If it isconsidered there is a conflict of interest, the member is excluded from participating further in thatappraisal.

The minutes of each Appraisal Committee meeting, which include the names of the memberswho attended and their declarations of interests, are posted on the NICE website.

Dr Jane AdamRadiologist, St George's Hospital, London

Professor A E AdesProfessor of Public Health Science, Department of Community Based Medicine, University ofBristol

Dr Amanda AdlerConsultant Physician, Cambridge University Hospitals Trust

Ms Anne AllisonNurse Clinical Advisor, Healthcare Commission

Dr Tom AslanGeneral Practitioner, The Hampstead Group Practice, London




http://www.nice.org.uk/

Professor David Barnett (Chair)Professor of Clinical Pharmacology, Leicester Royal Infirmary

Dr Matt BradleyHead of HTA and Business Environment, Sanofi-Aventis

Mrs Elizabeth BrainLay member

Mr David ChandlerLay member

Dr Karl ClaxtonProfessor of Health Economics, Department of Economics and Related Research, University ofYork

Dr Richard CooksonSenior Lecturer in Health Economics, School of Medicine Health Policy and Practice, Universityof East Anglia

Simon DixonReader in Health Economics, University of Sheffield

Mrs Fiona DuncanClinical Nurse Specialist, Anaesthetic Department, Blackpool Victoria Hospital, Blackpool

Professor Christopher EcclestonDirector, Centre for Pain Research, University of Bath

Dr Paul EwingsStatistician, Taunton and Somerset NHS Trust, Taunton

Professor John GeddesProfessor of Epidemiological Psychiatry, University of Oxford




Ms Eleanor GreyLay member

Mr Adrian GriffinVP Strategic Affairs, LifeScan, Johnson & Johnson Medical

Mr John GoulstonChief Executive, Barking, Havering and Redbridge Hospitals NHS Trust

Dr Rowan HillsonConsultant Physician and diabetologist, The Hillingdon Hospital, London

Professor Philip Home (Vice Chair)Professor of Diabetes Medicine, Newcastle University

Dr Terry JohnGeneral Practitioner, The Firs, London

Dr Vincent KirkbrideConsultant Neonatologist, Regional Neonatal Intensive Care Unit, Sheffield

Professor Richard LilfordHead of Division and Professor of Clinical Epidemiology, University of Birmingham

Dr Simon MaxwellSenior Lecturer in Clinical Pharmacology and Honorary Consultant Physician, Queen's MedicalResearch Institute, University of Edinburgh

Dr Alec MinersLecturer in Health Economics, London School of Hygiene and Tropical Medicine

Dr Ann RichardsonLay member

Mrs Angela SchofieldChairman, Bournemouth and Poole Teaching Primary Care Trust




Mr Cliff SnellingLay member

Mr Mike SpencerGeneral Manager, Facilities and Clinical Support Services, Cardiff and Vale NHS Trust

Dr Simon ThomasConsultant Physician and Reader in Therapeutics, Newcastle Hospitals NHS Foundation Trustand Newcastle University

Mr David ThomsonLay member

Dr Luke TwelvesGeneral Practitioner, Ramsey Health Centre, Cambridgeshire

Dr Norman VetterReader, Department of Primary Care and Public Health, School of Medicine, University of Cardiff

Dr Paul WatsonDirector of Commissioning, East of England Strategic Health Authority

B NICE project team

Each technology appraisal is assigned to a team consisting of one or more health technologyanalysts (who act as technical leads for the appraisal), a technical adviser and a projectmanager.

Rebecca TrowmanTechnical Lead

Zoe GarrettTechnical Adviser

Eloise SaileProject Manager




Appendix B: Sources of evidence considered by theCommittee

A. The assessment report for this appraisal was prepared by Peninsula Technology AssessmentGroup (PenTAG) Peninsula Medical School, Universities of Exeter and Plymouth with theWessex Institute for Health Research and Development (WIHRD) University of Southampton.

Bond M, Mealing S, Anderson R et al. The effectiveness and cost-effectiveness of cochlearimplants for severe to profound deafness in children and adults: a systematic review andeconomic mode, September 2007.

B. The following organisations accepted the invitation to participate in this appraisal. They wereinvited to comment on the draft scope, assessment report and the appraisal consultationdocument (ACD). Organisations listed in I and II were also invited to make written submissionsand have the opportunity to appeal against the final appraisal determination.

I) Manufacturers/sponsors:

Advanced Bionics UK

Cochlear Europe

MED-EL UK

Neurelec

II) Professional/specialist and patient/carer groups:

Auditory Verbal UK

Cochlear Implanted Children's Support Group

Deafness Research UK (formerly Defeating Deafness)

DELTA

Ear Foundation

Link Centre for Deafened People




British Cochlear Implants Group

National Association of Deafened People

National Cochlear Implant Users Association

National Deaf Children's Society

Royal National Institute for the Deaf

Sense

British Academy of Audiology

British Association of Audiological Physicians

British Association of Otorhinolaryngologists – Head and Neck Surgeons

British Association of Teachers of the Deaf

Royal College of General Practitioners

Royal College of Nursing

Royal College of Paediatrics and Child Health

Royal College of Physicians

Royal College of Speech and Language Therapists

Others

Department of Health

Welsh Assembly Government

III) Commentator organisations (without the right of appeal):

Department of Health, Social Services and Public Safety for Northern Ireland

EUCOMED

NHS Quality Improvement Scotland




NHS Supply Chain

National Coordinating Centre for Health Technology Assessment

Peninsula Technology Assessment

University College London – Department of Phonetics and Linguistics

C. The following individuals were selected from clinical specialist and patient advocatenominations from the non-manufacturer/sponsor consultees and commentators. Theyparticipated in the Appraisal Committee discussions and provided evidence to inform theAppraisal Committee's deliberations. They gave their expert personal view on cochlear implantsfor severe to profound deafness in children and adults by attending the initial Committeediscussion and/or providing written evidence to the Committee. They were also invited tocomment on the ACD.

Mr Christopher Raine, Clinical Specialist, Consultant ENT Surgeon, nominated by BritishAssociation of Otorhinolaryngologists – Head and Neck Surgeons

Mrs Louise Craddock, Clinical Specialist, Chair: British Cochlear Implant Group, nominatedby British Academy of Audiology

Professor Mark Lutman, Clinical Specialist, Professor of Audiology, Institute of Sound andVibration Research, nominated by British Academy of Audiology

Ms Tricia Kemp, Patient Expert; Chairperson, Cochlear Implanted Children's Support Group,nominated by National Cochlear Implant Users Association

Mr Nigel Williams, Patient Expert; Chairman, National Cochlear Implant Users Association,nominated by Cochlear Implanted Children's Support Group




Changes after publication

February 2014: implementation section updated to clarify that cochlear implants arerecommended as an option for treating children and adults with severe to profound deafness.Additional minor maintenance update also carried out.

March 2012: minor maintenance




About this guidance

NICE technology appraisal guidance is about the use of new and existing medicines andtreatments in the NHS in England and Wales.

This guidance was developed using the NICE multiple technology appraisal process.

We have produced a summary of this guidance for patients and carers. Tools to help you put theguidance into practice and information about the evidence it is based on are also available.

Your responsibility

This guidance represents the views of NICE and was arrived at after careful consideration of theevidence available. Healthcare professionals are expected to take it fully into account whenexercising their clinical judgement. However, the guidance does not override the individualresponsibility of healthcare professionals to make decisions appropriate to the circumstances ofthe individual patient, in consultation with the patient and/or guardian or carer.

Implementation of this guidance is the responsibility of local commissioners and/or providers.Commissioners and providers are reminded that it is their responsibility to implement theguidance, in their local context, in light of their duties to avoid unlawful discrimination and to haveregard to promoting equality of opportunity. Nothing in this guidance should be interpreted in away which would be inconsistent with compliance with those duties.

Copyright

© National Institute for Health and Clinical Excellence 2009. All rights reserved. NICE copyrightmaterial can be downloaded for private research and study, and may be reproduced foreducational and not-for-profit purposes. No reproduction by or for commercial organisations, orfor commercial purposes, is allowed without the written permission of NICE.




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